RT019 INSPIRATORY/EXPIRATORY FILTER— 510(k) K050927

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K050927 for RT019 INSPIRATORY/EXPIRATORY FILTER, Substantially Equivalent on 2005-08-01. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2005-04-13
Decision date: 2005-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Tamaki, Auckland, NZ

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.